Agency
The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.
The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.
FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.
Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.
Bristol-Myers Squibb is recalling 12,778 vials of Opdualag (nivolumab and relatlimab-rmbw) injection from one lot for lack of assurance of sterility.
GE HealthCare is recalling 173 Carescape Central Stations running software V3.0.5 because the system can enter a continuous reboot cycle, losing central monitoring of connected patients.
GE HealthCare is recalling 37 Maxicam gamma cameras because systems past guaranteed service may have been moved without adequate detector support, risking a detector fall.
GE HealthCare is recalling 15 Elscint Varicam gamma cameras because systems past guaranteed service may have been moved without adequate detector support, risking a detector fall.
Theken Companies is recalling 409 iNSitu Bipolar Hip System head assemblies in a downstream recall after BioPro femoral components failed transit testing, risking sterile barrier issues.
Sno Pac Foods is recalling 4,006 cases of Frozen Organic Spinach in 10 oz poly bags because the spinach has the potential to be contaminated with Listeria monocytogenes.
Coca-Cola Southwest Beverages is recalling 791 units of Sprite 12 oz cans in Texas over the potential presence of metal foreign material.
GE HealthCare is recalling three Elscint Helix gamma cameras because systems past guaranteed service may have been moved without adequate detector support, risking a detector fall.
Cardinal Health is recalling all lots of Salem Sump Anti-Reflux Valves after complaints of valve breakage due to excessive force during use, and is providing additional guidance for use.
GE HealthCare is recalling 28 Elscint SPX6 gamma cameras because systems past guaranteed service may have been moved without adequate detector support, risking a detector fall.
GE HealthCare is recalling 1,386 Millenium MG/MC gamma cameras because systems past guaranteed service may have been moved without adequate detector support, risking a detector fall.
Aspiro Pharma is recalling Ketorolac Tromethamine Injection USP 60 mg/2 mL across several lots because of particulate matter identified as glass.
GE HealthCare is recalling 11 Elscint Cardial gamma cameras because systems past guaranteed service may have been moved without adequate detector support, risking a detector fall.
Medline is recalling 8,267,150 Excelsior Medical 0.9% Sodium Chloride prefilled flush syringes because a limited quantity may not meet the required concentration of sodium chloride.
Becton Dickinson is recalling 4,283 BD Phoenix M50 Automated Microbiology Systems after product service credentials used by some technical support teams were accessed by an unauthorized actor.
Ocean's Kitchen is recalling 496 cases of shredded imitation crabmeat for potential contamination with Clostridium botulinum due to a risk of temperature abuse during chilled storage at the firm.
Southwind Foods is recalling Great American branded frozen raw shrimp skewers made under insanitary conditions in which the product may have been contaminated with Cesium-137.
Abdallah Incorporated is recalling 744 units of Lunds & Byerly's Pecan Caramel Clusters because the product may contain undeclared cashews.
Philips is recalling 29 Zenition 50 interventional fluoroscopic X-ray systems because corrosion of the image intensifier television control board may cause loss of imaging or poor image quality.
Cardinal Health is recalling all lots of Salem Sump dual lumen stomach tubes with anti-reflux valve after complaints of valve breakage due to excessive force during use.
Becton Dickinson is recalling 1,086 BD BACTEC Blood Culture Systems after product service credentials used by some technical support teams were accessed by an unauthorized actor.
Becton Dickinson is recalling 38 BD Veritor Connect Software units after product service credentials used by some technical support teams were accessed by an unauthorized actor.
Beckman Coulter is recalling 160 DxC 500i Clinical Analyzer modules over a software anomaly that may not apply user-specified manual dilution factors, risking false low or high results.
Southwind Foods is recalling Arctic Shores branded frozen cooked salad shrimp in 6 oz bags because it may have been contaminated with Cesium-137.
Cardinal Health is recalling all lots of Salem Sump PVC gastroduodenal tubes after complaints of anti-reflux valve breakage due to excessive force during use.